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Managing AI model biases in AI-enabled SaMDs
Medical device developers using AI in software as a medical device must avoid AI biases to optimise their SaMDs and limit health disparity perpetuation.
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Implementing digital health technologies for patient-centred trials
DHT adoption is growing as a way to de-risk clinical trials. But effective use of these technologies requires a structured approach to mitigate risks and maximise value. This blog and accompanying webinar provide a step-by-step guide to success with DHTs.
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Why translating core dossiers for marketing applications requires more than language skills
In this blog we outline why adoption of eCTD dossiers has increased and why translation requires regulatory expertise as well as language skills.
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A clinical trial linguist’s perspective on machine translation
Perspectives on what machine translation means for clinical trial translations from an experienced clinical trial linguist.
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How COAs and DHTs offer deep insights into patient experiences and treatment effects
A conversation with Sonia Bothorel, Managing Director, Mapi Research Trust and Outcome Measures Solutions.
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Why using COAs and DHTs together is the future of clinical research
Though both COAs and DHTs are tools used to evaluate a treatment’s impact, they often exist in separate spheres, rarely integrated. We argue that combining these two approaches in the same study can help researchers gather better data and improve the likelihood of regulatory approval.
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Digital health: why evaluating human factors is essential
With the rapidly evolving technology, digital health is transforming healthcare, emerging as a promising solution to reduce rising healthcare costs and improve patient care.
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Digital health: managing cybersecurity risks
When developing a new digital health device, as well as maintaining an existing device, securing the device from cybersecurity attacks is critical.
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Unlocking quality in machine translation: The impact of ISO 18587 certification on clinical research
ISO 18587 certification helps ensure consistency and quality in the post-editing process, fostering trust and confidence in machine-translated content across various industries and applications.
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The impact of AI on the evolution of machine translation
From its nascent stages to the sophisticated systems we employ today, machine translation has become an indispensable efficiency generating tool.
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Insights from PSI 2024: Advancements in digital health technology
ICON’s statisticians share insights from the PSI’s 2024 conference where they presented on advancements in digital health technology and decision making.
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Digital health : patient safety and the next frontier
Medical and wearable devices, remote in-vitro diagnostics and digital therapeutic products - the rapidly evolving world of digital health is bringing more and more devices into patients’ hands. But along with the benefits, there are safety considerations for people and data.
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How data intelligence tools are enhancing signal detection methods
Advancements in intelligence tools such as ICON’s Signet help overcome challenges with data volume, complexity and completeness to accurately and rapidly detect safety signals to ensure patient safety throughout the drug’s lifecycle.
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Anatomic pathology in the digital age
The development of new, innovative digital technologies has provided the tools to rethink the way we design and conduct clinical trials. One area that has been particularly impacted by this digital age is anatomical pathology.
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The data revolution: Big data’s role in clinical trial patient recruitment, retention and engagement
How big data can be leveraged by pharma to solve key challenges in patient recruitment and drug development.
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Data capture: The benefits and evolution of eCOA
As the demand for improving patient safety in clinical trials continues to rise, so will the use of technology as a way to better capture data and enhance clinical outcome assessments (COAs).
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Benefits of implementing a unified patient experience in clinical trials
Inconsistent patient engagement has been a leading challenge in clinical trials. Learn how to overcome this challenge and maximise your trial's potential today.
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Scientific publications technology solutions
This is the third article in a three-part series from ICON’s webinar, “Evolving Best Practices for Working with Authors— Authorship and Beyond.”
In this section
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Digital Disruption
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Clinical strategies to optimise SaMD for treating mental health
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Digital Disruption: Surveying the industry's evolving landscape
- AI and clinical trials
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Clinical trial data anonymisation and data sharing
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Clinical Trial Tokenisation
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Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
- mHealth wearables
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Personalising Digital Health
- Real World Data
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The triad of trust: Navigating real-world healthcare data integration
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Decoding AI in software as a medical device (SaMD)
- Software as a medical device (SaMD)
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Clinical strategies to optimise SaMD for treating mental health
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Patient Centricity
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Accelerating clinical development through DHTs
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Agile Clinical Monitoring
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Capturing the voice of the patient in clinical trials
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Charting the Managed Access Program Landscape
- Representation and inclusion in clinical trials
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Exploring the patient perspective from different angles
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Patient safety and pharmacovigilance
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A guide to safety data migrations
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Taking safety reporting to the next level with automation
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Outsourced Pharmacovigilance Affiliate Solution
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The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
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Sponsor and CRO pharmacovigilance and safety alliances
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Understanding the Periodic Benefit-Risk Evaluation Report
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A guide to safety data migrations
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Patient voice survey
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Patient Voice Survey - Decentralised and Hybrid Trials
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Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
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Using longitudinal qualitative research to capture the patient voice
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Prioritising patient-centred research for regulatory approval
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Accelerating clinical development through DHTs
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Regulatory Intelligence
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Accelerating access
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Meeting requirements for Joint Clinical Assessments
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Navigating the regulatory landscape in the US and Japan:
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Preparing for ICH GCP E6(R3) implementation
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An innovative approach to rare disease clinical development
- EU Clinical Trials Regulation
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Using innovative tools and lean writing processes to accelerate regulatory document writing
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Current overview of data sharing within clinical trial transparency
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Global Agency Meetings: A collaborative approach to drug development
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Keeping the end in mind: key considerations for creating plain language summaries
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Navigating orphan drug development from early phase to marketing authorisation
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Procedural and regulatory know-how for China biotechs in the EU
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RACE for Children Act
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Early engagement and regulatory considerations for biotech
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Regulatory Intelligence Newsletter
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Requirements & strategy considerations within clinical trial transparency
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Spotlight on regulatory reforms in China
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Demystifying EU CTR, MDR and IVDR
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Transfer of marketing authorisation
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Exploring FDA guidance for modern Data Monitoring Committees
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Streamlining dossier preparation
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Accelerating access
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Therapeutics insights
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Endocrine and Metabolic Disorders
- Cardiovascular
- Cell and Gene Therapies
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Central Nervous System
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A mind for digital therapeutics
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Challenges and opportunities in traumatic brain injury clinical trials
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Challenges and opportunities in Parkinson’s Disease clinical trials
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Early, precise and efficient; the methods and technologies advancing Alzheimer’s and Parkinson’s R&D
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Key Considerations in Chronic Pain Clinical Trials
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ICON survey report: CNS therapeutic development
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A mind for digital therapeutics
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Glycomics
- Infectious Diseases
- NASH
- Obesity
- Oncology
- Paediatrics
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Respiratory
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Rare and orphan diseases
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Advanced therapies for rare diseases
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Cross-border enrollment of rare disease patients
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Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
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Diversity, equity and inclusion in rare disease clinical trials
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Identify and mitigate risks to rare disease clinical programmes
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Leveraging historical data for use in rare disease trials
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Natural history studies to improve drug development in rare diseases
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Patient Centricity in Orphan Drug Development
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The key to remarkable rare disease registries
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Therapeutic spotlight: Precision medicine considerations in rare diseases
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Advanced therapies for rare diseases
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Endocrine and Metabolic Disorders
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Transforming Trials
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Accelerating biotech innovation from discovery to commercialisation
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Demystifying the Systematic Literature Reviews
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Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
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From bottlenecks to breakthroughs
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Linguistic validation of Clinical Outcomes Assessments
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More than monitoring
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Optimising biotech funding
- Adaptive clinical trials
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Best practices to increase engagement with medical and scientific poster content
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Decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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Decentralised and Hybrid clinical trials
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Practical considerations in transitioning to hybrid or decentralised clinical trials
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Navigating the regulatory labyrinth of technology in decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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eCOA implementation
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Blended solutions insights
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Clinical trials in Japan: An enterprise growth and management strategy
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How investments in supply of CRAs is better than competing with the demand for CRAs
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The evolution of FSP: not just for large pharma
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Embracing a blended operating model
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Observations in outsourcing: Survey results show a blended future
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Clinical trials in Japan: An enterprise growth and management strategy
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Implications of COVID-19 on statistical design and analyses of clinical studies
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Improving pharma R&D efficiency
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Increasing Complexity and Declining ROI in Drug Development
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Innovation in Clinical Trial Methodologies
- Partnership insights
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Risk Based Quality Management
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Transforming the R&D Model to Sustain Growth
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Accelerating biotech innovation from discovery to commercialisation
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Value Based Healthcare
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Strategies for commercialising oncology treatments for young adults
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US payers and PROs
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Accelerated early clinical manufacturing
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Cardiovascular Medical Devices
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CMS Part D Price Negotiations: Is your drug on the list?
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COVID-19 navigating global market access
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Ensuring scientific rigor in external control arms
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Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
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Health technology assessment
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Perspectives from US payers
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ICER’s impact on payer decision making
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Making Sense of the Biosimilars Market
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Medical communications in early phase product development
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Navigating the Challenges and Opportunities of Value Based Healthcare
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Payer Reliance on ICER and Perceptions on Value Based Pricing
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Payers Perspectives on Digital Therapeutics
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Precision Medicine
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RWE Generation Cross Sectional Studies and Medical Chart Review
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Survey results: How to engage healthcare decision-makers
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The affordability hurdle for gene therapies
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The Role of ICER as an HTA Organisation
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Integrating openness and precision for competitive advantage
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Strategies for commercialising oncology treatments for young adults
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